Cushion-to-frame component for an interfacing structure

ABSTRACT

An interfacing structure for a mask system includes a cushion component adapted to contact the patient&#39;s face in use and a cushion-to-frame component provided to the cushion component. The cushion-to-frame component is structured to secure the cushion component to a mask frame of the mask system. The cushion-to-frame component includes a cushion side adapted to interface with the cushion component and a frame side adapted to interface with the mask frame. The cushion side includes a platform to engage and support the cushion component. The platform provides an engagement surface to engage the cushion component and inner and outer flanges provided to opposing ends of the platform to guide, support and/or retain the cushion component on the platform.

CROSS-REFERENCE TO APPLICATION

This application claims the benefit of U.S. Provisional Application Nos.61/457,261, filed Feb. 14, 2011, and 61/457,751, filed May 26, 2011,each of which is incorporated herein by reference in its entirety.

FIELD OF TECHNOLOGY

The present technology relates to an interface between a human and apiece of equipment, for example respiratory devices that include aninterfacing structure.

BACKGROUND OF TECHNOLOGY

In a number of fields, such as respiratory therapy, apparatus fordelivery of therapy includes a more rigid component and a soft,cushioning component positioned between the patient and the rigidcomponent.

In the case of a respiratory device, the more rigid component may be amask frame at least partly defining a nose-receiving chamber. The maskframe may include a flange around its periphery. The cushioningcomponent or interfacing structure may be glued or otherwise coupled tothe flange.

The present technology provides alternative arrangements for coupling acushioning component or interfacing structure to a mask frame.

SUMMARY OF TECHNOLOGY

One aspect of the disclosed technology relates to a cushion-to-framecomponent structured to facilitate assembly/disassembly of theinterfacing structure to the mask frame.

Another aspect of the disclosed technology relates to a cushion-to-framecomponent structured to enhance retention to the frame.

Another aspect of the disclosed technology relates to a cushion-to-framecomponent structured to enhance cushion-to-frame seal.

Another aspect of the disclosed technology relates to a cushion-to-framecomponent structured to enhance durability and/or facilitatemanufacture.

Another aspect of the disclosed technology relates to an interfacingstructure for a mask system including a cushion component adapted tocontact the patient's face in use and a cushion-to-frame componentprovided to the cushion component. The cushion-to-frame component isstructured to secure the cushion component to a mask frame of the masksystem. The cushion-to-frame component includes a cushion side adaptedto interface with the cushion component and a frame side adapted tointerface with the mask frame. The cushion side may include a platformto engage and support the cushion component. The cushion side mayinclude a glue channel to permit the passage of glue and capture excessglue. The platform provides an engagement surface to engage the cushioncomponent and inner and outer flanges provided to opposing ends of theplatform to guide, support and/or retain the cushion component on theplatform.

Another aspect of the disclosed technology relates to an interfacingstructure for a mask system including a cushion component adapted tocontact the patient's face in use and a cushion-to-frame componentprovided to the cushion component. The cushion-to-frame component isstructured to secure the cushion component to a mask frame of the masksystem. The cushion-to-frame component may be molded in TPE.

Another aspect of the disclosed technology relates to an interfacingstructure for a mask system including a cushion component adapted tocontact the patient's face in use and a cushion-to-frame componentprovided to the cushion component. The cushion-to-frame component isstructured to secure the cushion component to a mask frame of the masksystem. The cushion-to-frame component includes a sealing lip adapted toengage the mask frame and provide a seal. The sealing lip is disposed atan angle and has a length to enhance seal and control ease of insertionor assembly. The sealing lip may also have inner and/or outer radiiwhere it joins the body of the cushion-to-frame component to enhanceseal and control ease of insertion or assembly. The sealing lip may alsohave a surface finish such as frosting or other surface roughening toincrease the ease of insertion or assembly.

Another aspect of the disclosed technology relates to an interfacingstructure for a mask system including a cushion component adapted tocontact the patient's face in use and a cushion-to-frame componentprovided to the cushion component. The cushion-to-frame component isstructured to secure the cushion component to a mask frame of the masksystem. The cushion-to-frame component includes a sealing lip adapted toprogressively engage the mask frame by adjusting the position of thesealing lip's height on a side wall of the cushion-to-frame component,varying the length of the sealing lip around the perimeter of thecushion-to-frame component, and/or varying the angle of the sealing lipwith respect to the inner wall.

Another aspect of the disclosed technology relates to an interfacingstructure for a mask system including a cushion component adapted tocontact the patient's face in use and a cushion-to-frame componentprovided to the cushion component. The cushion-to-frame component isstructured to secure the cushion component to a mask frame of the masksystem. The cushion-to-frame component includes at least one clipportion adapted to engage a respective slot provided on the mask frame.The at least one clip portion extends from a wall of thecushion-to-frame component. The wail includes a rib adjacent each of theside clip portions structured and arranged to engage the mask frame andenhance the force at which a sealing lip adjacent the clip portionengages the frame. The wall may also include additional adjacent ribs tostiffen and control the flexibility of the clip portion.

Another aspect of the disclosed technology relates to a cushion-to-framecomponent structured to secure a cushion component to a mask frame ofthe mask system. The cushion-to-frame component may include one or moreribs provided between inner and outer walls of the cushion-to-framecomponent to enhance rigidity and assist to align the cushion-to-framecomponent to the frame.

Another aspect of the disclosed technology relates to a cushion-to-framecomponent that is constructed and arranged to impart a 3-dimensionalshape to a 2-dimensional cushion component that is assembled thereto.Furthermore, another aspect of the disclosed technology relates to aprocess in which a flat cushion component is assembled to a curvedcushion-to-frame component, and in which a curved shape is imparted tothe flat cushion component.

Another aspect of the disclosed technology relates to an interfacingstructure for a mask system including a cushion component adapted tocontact a region of the patient's face in use, the cushion componentbeing manufactured to have a two-dimensional shape, and acushion-to-frame component including a cushion surface constructed andarranged to have a three dimensional shape and to impart that shape tothe cushion component when the cushion component is assembled to thecushion surface of the cushion-to-frame component.

Another aspect of the disclosed technology relates to a method formanufacturing an interfacing structure for a mask system. The methodincludes providing a cushion-to-frame component including a cushionsurface having a three-dimensional shape, and assembling a cushioncomponent having a two-dimension shape to the cushion surface of thecushion-to-frame component such that that the cushion-to-frame componentimparts its three-dimensional shape to the cushion component.

Other aspects, features, and advantages of this technology will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousexamples of this technology. In such drawings:

FIG. 1 is a side view of a mask system including a foam-basedinterfacing structure according to an example of the disclosedtechnology;

FIG. 2 is a front view of the mask system of FIG. 1;

FIG. 3 is a perspective view of a cushion-to-frame component for afoam-based interfacing structure according to an example of thedisclosed technology;

FIG. 4 is another perspective view of the cushion-to-frame component ofFIG. 3;

FIG. 5 is a plan view of a frame contacting side of the cushion-to-framecomponent of FIG. 3;

FIG. 6 is a plan view of a cushion contacting side of thecushion-to-frame component of FIG. 3;

FIG. 7 is a bottom view of the cushion-to-frame component of FIG. 3;

FIG. 8 is a side view of the cushion-to-frame component of FIG. 3;

FIG. 9 is a cross-sectional view through line 9-9 of FIG. 5;

FIG. 9 a is an enlarged view of a portion of FIG. 9;

FIG. 10 is a cross-sectional view through line 10-10 of FIG. 5;

FIG. 11 is a cross-sectional view through line 11-11 of FIG. 5;

FIG. 11 a is an enlarged view of a portion of FIG. 11;

FIG. 12 is an enlarged perspective view of a side clip portion of thecushion-to-frame component of FIG. 3;

FIG. 13 is an enlarged perspective view of a bottom clip portion of thecushion-to-frame component of FIG. 3;

FIG. 14 is another enlarged perspective view of a bottom clip portion ofthe cushion-to-frame component of FIG. 3;

FIG. 15 is a partial perspective view of a cushion-to-frame componentand a foam-based interfacing structure according to an example of thedisclosed technology;

FIG. 16 is another partial perspective view of the cushion-to-framecomponent and the foam-based interfacing structure of FIG. 15;

FIG. 17 is a top view of a cushion-to-frame component and a foam-basedinterfacing structure according to an example of the disclosedtechnology;

FIGS. 18-1 to 18-3 are schematic views of cushion-to-frame componentsaccording to alternative examples of the disclosed technology;

FIG. 19 is a cross-sectional view of a cushion-to-frame component in achin region according to an example of the disclosed technology;

FIG. 20 is a cross-sectional view of a cushion-to-frame component in achin region according to another example of the disclosed technology;

FIG. 21 is a cross-sectional view of a cushion-to-frame component in achin region according to another example of the disclosed technology;

FIG. 22 is a cross-sectional view of a cushion-to-frame component in achin region according to another example of the disclosed technology;

FIG. 23 is a perspective view of a mask system including a foam-basedinterfacing structure and foam-based forehead support pad according toan example of the disclosed technology;

FIG. 24 is a perspective view of a foam-based forehead support padaccording to an example of the disclosed technology;

FIGS. 25-1 to 25-5 are perspective views of pad support portionsaccording to alternative examples of the disclosed technology;

FIG. 26 is a perspective view of a forehead support and cushioningcomponent according to an example of the disclosed technology;

FIG. 27 is a cross-sectional view of a cushion-to-frame component and afoam-based interfacing structure according to an example of thedisclosed technology;

FIG. 28 is a cross-sectional view of a cushion-to-frame component and afoam-based interfacing structure according to another example of thedisclosed technology;

FIG. 29 is a cross-sectional view of a foam-based interfacing structureaccording to another example of the disclosed technology; and

FIG. 30 is a cross-sectional view of a cushion-to-frame componentaccording to another example of the disclosed technology.

DETAILED DESCRIPTION OF ILLUSTRATED EXAMPLES

The following description is provided in relation to several examples(most of which are illustrated, some of which may not) which may sharecommon characteristics and features. It is to be understood that one ormore features of any one example may be combinable with one or morefeatures of the other examples. In addition, any single feature orcombination of features in any of the examples may constitute additionalexamples.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen.

Each illustrated example includes features that may be adapted for useand/or incorporated into the examples and/or components of theinterfacing structures described in PCT Application Nos.PCT/AU2009/000262 and PCT/AU2009/001144, as would be apparent to thoseof ordinary skill in the art. PCT Application Nos. PCT/AU2009/000262 andPCT/AU2009/001144 are each incorporated herein by reference in itsentirety. For example, the foam based interface of the presenttechnology may be retrofit or otherwise provided to cushion framesdescribed in these applications, e.g., the QUATTRO™ mask by ResMed.

While each illustrated example is described as being implemented into afoam-based interfacing structure of the type described in PCTApplication Nos. PCT/AU2009/000262 and PCT/AU2009/001144, eachillustrated example may be implemented into other interface types, e.g.,silicone-based interfacing structures, gel-based interfacing structures,For example, the present technology may be retrofit or otherwiseprovided to existing masks, e.g., non-foam cushions.

One or more examples may include exemplary dimensions. Although specificdimensions and ranges may be provided, it is to be understood that thesedimensions and ranges are merely exemplary and other dimensions andranges are possible depending on application. For example, ranges thatvary from those provided +/−10% may be suitable for particularapplications.

Mask System

FIGS. 1 and 2 show a full-face mask system 10 including a frame 20 and afoam-based interfacing structure 30 (e.g., cushion) provided to theframe and adapted to contact the patient's face. The full-face masksystem is intended for use in positive pressure therapy for users withObstructive Sleep Apnea (OSA) or another respiratory disorder.

While each example below is described as including a full-face interfacetype, aspects of the technology may be adapted for use with othersuitable interface types, e.g., nasal interface, nozzles, nasal prongs,nasal cradle, etc.

Foam-Based Interfacing Structure

The foam-based interfacing structure 30 includes a foam cushioningcomponent or cushion component 40 and a cushion-to-frame component 50provided to the foam cushioning component 40. The cushioning component40 is structured to contact the patient's face and the cushion-to-framecomponent 50 is structured to secure the interfacing structure to themask frame 20.

In one form of the present technology, the foam cushioning component 40is manufactured to have a relatively flat, two-dimensional surface onone side. Preferably, the cushioning component 40 extends in a lengthdimension and a width dimension.

Exemplary materials and properties for the foam cushioning component areprovided in PCT Application Nos. PCT/AU2009/000262 andPCT/AU2009/001144.

Clip Component

FIGS. 3 to 14 illustrate a cushion-to-frame component 50 according to anexample of the technology. As illustrated, the cushion-to-framecomponent 50 is in the form of a clip component of clip portion. Theclip component is structured to facilitate assembly/disassembly of theinterfacing structure to the mask frame, enhance clip retention, enhancecushion-to-frame seal, enhance durability, and/or facilitatemanufacture.

In one preferred form, the cushion-to-frame component 50 has a curved,preferably three-dimensional shape that is complementary to a shape of aface of a person. Preferably, the cushion-to-frame component extends ina length dimension, a width dimension, and a depth dimension. See forexample the cushion contacting side 60 of the cushion-to-frame component50 in FIGS. 7, 8 and 9. For example, as shown in FIG. 7, thecushion-to-frame component has a shape that follows a chin region of aface. In one preferred form, the cushion-to-frame component 50 hasdifferent roll or bank angles in different regions of thecushion-to-frame component 50. The different roll or bank angle is, inone form, constructed to align the cushion contacting side 60 of thecushion-to-frame component 50 at an angle that is approximatelyorthogonal to the surface of the face, in at least some regions of theface, in use. In another form, the different roll or bank angle isconstructed to align the cushion contacting side 60 of thecushion-to-frame component 50 at an angle that is not orthogonal to thesurface of the face, for example, at an acute angle to the surface ofthe face in use.

Material

The cushion-to-frame component 50 may be constructed of a materialhaving greater structural integrity than the foam cushioning component40 so as to aid assembly of the cushioning component 40 to the frame 20.For example, the cushion-to-frame component 50 may be constructed of amaterial providing sufficient flexibility, strength, and processibility,e.g., a material having the flexibility of rubber, strength of plastics,and processibility of thermoplastics. In an example, thecushion-to-frame component 50 may be molded of TPE such as Hytrel®,e.g., specifically Hytrel® 5556 by DuPont™. However, thecushion-to-frame component 50 may be constructed of other suitablematerials, e.g., harder, denser and/or lower permeability foam than thefoam of the foam cushioning component (e.g., a foam having a densitygreater than 50 kg/m³); nylon; polycarbonate; polypropylene; silicone(e.g., silicone having a hardness of at least 70 Shore A); cast ormolded microcellular polyurethane foam.

In an example, the cushion-to-frame component 50 may be integrallyformed in one piece with the cushioning component 40 but includedifferent properties than the cushioning component, e.g., harder, denserand/or lower permeability foam than foam cushioning component.

Contour, Shape, and Size

The clip component 50 includes a cushion contacting side or cushion side60 (e.g., see FIGS. 3 and 6) adapted to support or otherwise interfacewith the cushioning component 40 and a frame contacting side or frameside 70 (e.g., see FIGS. 4 and 5) adapted to engage or otherwiseinterface with the mask frame 20. The shape of the top surface of thecushion side may be used to correctly align and position the cushioningcomponent with the patient's face, e.g., see WO 2010/028425. Forexample, the clip component may distort or orient the cushioningcomponent into a particular shape. Since the clip component isrelatively more rigid than the cushioning component, the cushioningcomponent is forced to retain the shape or position of the clipcomponent.

The general contour and shape of the frame contacting side may beconfigured to align with the frame to which it is attached. The generalcontour and shape of the cushion contacting side may be used to shapethe cushion component, e.g., foam-based cushioning componentsufficiently compliant so it will adapt to the shape of the cushioncontacting side when secured thereto.

Also, the clip component may be provided in alternative sizescorresponding to alternative size cushions, e.g., small, medium, large,etc. Alternatively, a single size clip component may be structured tosupport alternative size cushions. In another example, different clipsmay be manufactured to customize the shape of a cushion for individualuser anthropometrics, sizing, and/or other purposes. Possibly, a single,common size frame and a single, common size cushion may be used.Alternatively, various frames, clips, and cushions may be made andvarious combinations may be used to customize the size and fit. If thecushion is not permanently attached to the clip, e.g., silicone cushion,it may be interchangeable. If the cushion is permanently attached to theclip, e.g., foam cushion, several different clip and cushion combinationassemblies may be manufactured.

Frame Contacting Side

The frame contacting side 70 includes a pair of side clip portions 72 onrespective sides of the component and a bottom or lower clip portion 74adapted to engage respective slots provided on the mask frame (e.g., seeside slots 22 and bottom slot 24 in frame 20 in FIG. 2). It should beappreciated that the frame contacting side may have any suitable numberof clip portions, and the number of slots in the mask frame may bevaried according to the number of clip portions.

In the illustrated example, the side clip portions include a differentstructure or configuration than the bottom clip portion. However, itshould be appreciated that the clip portions may have other suitablearrangements, e.g., bottom clip portion similar structure to side clipportions.

Side Clip Portions

As illustrated, each side clip portion 72 extends from an inner wall 52of the cushion-to-frame component 50. Each side clip portion 72 isrelatively thick and defines a shoulder 73 adapted to engage an edge ofthe corresponding frame slot. Each side clip portion 72 includescontoured finger grips 75 (e.g., see FIG. 12) to facilitate assembly. Inaddition, one or more recesses or cut-outs 77 (e.g., three recesses asshown in FIGS. 3, 4, 8, 10, 11, and 12) are provided to a base portion76 adjacent each side clip portion. As illustrated, each base portion 76extends between the inner wall 52 and an outer wall 54 of the componentadjacent a respective side clip portion. Such recesses also enhance gripof the component to facilitate assembly. In an example, one or more ribsmay be provided within the recesses or cut-outs 77, e.g., to increasethe stiffness of the clip to enhance feedback duringassembly/disassembly.

Ribs

Also, as best shown in FIGS. 8 and 12, a central rib 78 and side ribs 79are provided to the inner wall 52 between each side clip portion 72 andthe base portion 76. As illustrated, the central rib 78 is contouredalong its length and protrudes further outwardly from the inner wallthan the side ribs 79. However, other suitable rib configurations arepossible. In use, the ribs are structured and arranged to control theflexibility of the side clip portion 72, e.g., to increase stiffness andtherefore enhance retention.

In addition to the base portions 76, one or more additional ribs 85(e.g., see FIG. 4) are provided between the inner and outer walls 52,54, e.g., to enhance rigidity. Ribs 85 may also assist to align the clipto the frame, so that the clip wall does not incorrectly jam with theframe wall. That is, the ribs 85 are structured to prevent “hang up” ofthe clip on the frame, i.e., ribs aid insertion by preventingmisalignment of the clip to the frame.

Reinforcement of Frame Seal

In an example, the side clip portions 72 may be configured such that theside clip portions are squeezed or forced towards one another whenengaged with respective slots 22 of the mask frame 20. Also, the ribs 78provided adjacent each clip portion 72 engage the frame and enhance theforce at which the sealing lip adjacent the side clip portions engagethe frame, so as to reinforce the seal at these opposite sides of thecomponent. That is, the seal is reinforced along a generally concave orpear-shaped portion of the component.

Bottom Clip Portion

The bottom clip portion 74 has a lower profile than the side clipportions and does not provide finger grips. The bottom clip portion 74extends from the inner wall 52 and defines a shoulder 81 (e.g., FIG. 14)adapted to engage an edge of the corresponding frame slot. A rib 83(e.g., see FIGS. 7, 13 and 14) is provided to the inner wall 52 adjacentthe bottom clip portion 74 to control the flexibility of the bottom clipportion 74, e.g., to increase stiffness and therefore enhance retention.As illustrated, the rib is tapered along its length, however othersuitable rib configurations are possible. Also, more than one rib may beprovided adjacent the bottom clip portion 74, e.g., to provideadditional support, as shown in FIGS. 19, 21, and 22 for example.

As shown in FIG. 14, the bulbous free end of the bottom clip portion 74has been thickened to enlarge the surface area or snap engagement lengthprovided by the shoulder 81 adapted to engage an edge of thecorresponding frame slot, e.g., to enhance retention. As shown in FIG. 9a, the shoulder 81 may have a length dl of about 1-3 mm, e.g., about 2mm, about 1.8 mm. Also, d2 in FIG. 9 a may be about 18-22 mm, e.g.,about 20 mm. However, it should be appreciated that other suitabledimensions are possible, e.g., depending on interface type.

Sealing Lip

A sealing lip 90 extends along the perimeter of the inner wall 52towards the interior of the component. In use, the sealing lip 90 isadapted engage an inner wall of the mask frame and provide a seal, e.g.,prevent leak between the mask frame and the cushion-to-frame component.As shown in FIG. 10, a lower surface 52(1) of the inner wall is offsetoutwards from an upper surface 52(2) of the inner wall to increase thelength of the sealing lip. Also, the sealing lip is suitably angled toallow folding of the lip towards the inner wall in use.

Progressive Engagement of Sealing Lip

In an example, the sealing lip may be structured to progressively engagethe frame, i.e., sealing lip configured to engage the frame in steps.For example, the length of travel of the sealing lip on the frame may bemodified by adjusting the position of the sealing lip's height on theside wall. Also, the length of the sealing lip may be varied around theperimeter of the component, e.g., sealing lip longer on the sides of thecomponent. In addition, the angle of the sealing lip with respect to theinner wall may be varied. The angle and/or length of the sealing lip mayenhance seal and/or control ease of insertion or assembly.

Exemplary Dimensions

FIGS. 10 and 11 show exemplary dimensions according to an example of thetechnology. For example, as shown in FIG. 10, d1 is about 2 to 2.5 mm(e.g., 2.2 mm), d2 is about 1.8 to 2.3 mm (e.g., 2.0 mm), t is about0.25 to 0.45 mm (e.g., 0.35 mm), R is about 0.05 to 0.25 mm (e.g., 0.1mm), and a is about 40-60°, e.g., 51°. In FIG. 11, d3 may be about 11-12mm, e.g., 11.5 mm. In an example, the wall thickness of the clipcomponent may be about 1.3-1.5 mm. Although specific dimensions areindicated, it is to be understood that these dimensions are merelyexemplary and other dimensions are possible depending on application.

In an alternative example, the internal radius of the sealing lip (e.g.,identified by dimension R in FIG. 10) may be replaced with a sharpinternal edge.

Cushion Contacting Side

As best shown in FIGS. 3, 6, 9 a, 10, 11 and 11 a, the cushioncontacting side 60 provides a platform 62 adapted to engage and supportat least a portion of the cushioning component 40. The cushioningcomponent may be attached to the cushion contacting side 60 in anysuitable manner, e.g., adhesive, insert molding, mechanical interlock,etc. Exemplary adhesives include cyanoacrylate (e.g., Loctite®),polyurethane hot melt glue, polyurethane, and other suitable adhesivesstructured to prevent detachment and brittleness.

Preferably, the cushioning component 40 is relatively soft and flexiblecompared to the cushion-to-frame component 50, and thus when assembled,the cushioning component 40 adopts a shape that is imparted by thecushion-to-frame component 50. This arrangement can simplify amanufacturing process, and enable the construction of an interfacingstructure that more closely matches a seal-forming portion adapted toengage the patient's face. For example, in one preferred form, thecushioning component 40 can be manufactured to have a two-dimensionalshape, and subsequently held by the cushion-to-frame component in athree-dimensional shape that is complementary to the correspondingportion of the patient's face. For example, the cushioning component 40can be arranged at least in some regions to be aligned to make an anglewith the surface of the face, rather than being orthogonal to the face.

That is, the cushioning component 40 may be manufactured to have arelatively flat, two-dimensional shape, e.g., the cushioning componentincludes a surface on one side that extends in a length dimension and awidth dimension. When the cushioning component 40 is attached to thecushion-to-frame component 50, the cushion-to-frame component 50 isconstructed and arranged to impart a three-dimensional shape to thetwo-dimensional cushion component, i.e., add a depth dimension to thecushioning component to match the curvature of the user's face. Itshould be appreciated that the cushion-to-frame component may bestructured to provide alternative curvatures along its perimeter (e.g.,different roll or bank angles in different regions of thecushion-to-frame component) in order to adjust the shape or angle, e.g.,depth dimension, imparted to different regions of the cushioningcomponent. For example, the cushion-to-frame component may be structuredto impart different shapes or angles, e.g., different depths, to thecushioning component in the nose bridge region with respect to the chinregion. In one example, the cushion-to-frame component may be structuredto twist the cushioning component about its longitudinal axis.

Platform

In the illustrated example, the platform 62 provides an engagementsurface 64 adapted to engage the cushioning component and to form thecushion component into the shape and position for an effective (e.g.,comfortable and sealed) patient interface. Inner and/or outer flanges orlips 66, 68 may be provided to opposing ends of the platform to helpguide, support and/or retain the cushioning component on the platform 62and/or to cover the joint of the cushioning component and the adhesive.For example, the flanges may define a nest for the cushioning componentwithin the platform to help reduce misalignment between the clipcomponent and the cushioning component. Also, the flanges may preventoverflow, e.g., of adhesive during assembly of the cushioning component,over ends of the platform. In addition, the flanges may provide a guideto aid manufacturing alignment. The flanges may also help with cushionblow-out and/or biasing cushion wall to roll.

In an example, the engagement surface 64 may be considered a “channel”or “glue channel” cut into the cushion contacting side 60 to permit thepassage of glue and capture excess glue. For example, the generallytriangular-shaped channels 65(1), 65(2) provide glue tracks to receiveexcess glue. It should be appreciated that the channels 65(1), 65(2) mayhave other suitable widths, depths, shapes, and/or positions. The innerflange 66 may be provided as a result of cutting or otherwise formingthe inner glue channel 65(1). The relatively flat shelf 67 adjacent theouter flange 68 provides a “flange” for the outer glue channel 65(2).The outer flange 68 is in the form of a cushion guide lip to provide analignment feature when positioning and locating the cushioning componentduring the gluing process. In addition, the outer flange 68 hides theedge of the cushioning component so as to hide the glue joint whichcould appear untidy. However, it should be appreciated that the channelsand flanges may be optional features, e.g., depending on the assemblymethod and/or adhesive.

As best shown in FIG. 11 a, the engagement surface 64 includes anon-linear portion along its width, e.g., including incline portions,decline portions, flat portions, etc. However, it should be appreciatedthat the engagement surface may be relatively flat. The non-linear oruneven engagement surface may be help to shape the cushioning componentand/or retain the cushioning component on the platform. For example, thenon-linear portion of the engagement surface may positively locate thecushioning component, provide larger surface area for retention, and/ordefine one or more notches to define stop or retaining surfaces.

Assembly

In use, the clip component is attached or otherwise secured to thecushioning component to establish the interfacing structure, and thenthe interfacing structure is engaged with the mask frame by insertingthe clip portions of the clip component into respective slots of themask frame, e.g., with a snap-fit. The clip portions may each provide anaudible click, which provides audible and tactile feedback regarding aproper connection.

In addition, the clip portions are structured to reduce the assembly anddisassembly forces. For example, assembly force may be less than 75N,e.g., 60-70N, 60-65N, e.g., about 65N. Disassembly force may be lessthan 17N, e.g., 10-15N, 11-14N, about 13N. Although specific forces areindicated, it is to be understood that these forces are merely exemplaryand other forces are possible depending on application, e.g., interfacetype. Also, the clip portions may be tuned to desiredassembly/disassembly forces.

Structure to Prevent Foam in the Eyes

In an example, as shown in FIGS. 15 and 16, arcuate-shaped protrusionsor wings 69 may be provided to respective sides of the cushioncontacting side 60 of the clip component 50 adjacent side of noseregions of the foam cushioning component 40. Such protrusions or wingsare positioned proximal to the patient's eyes in use so as to hold thefoam cushioning component away from the patient's eyes.

Also, as shown in FIGS. 15 and 16, the foam cushioning component 40 mayinclude scalloped or inwardly curved surfaces 49 in these side-of-noseregions (e.g., adjacent respective protrusions 69) to reduce the amountof foam near the patient's eyes.

In addition, as shown in FIG. 17, the clip component 50 and cushioningcomponent 40 attached thereto may include a scooped or inwardly curvedportion 45 in the side of nose region so that the cushioning componentis positioned away from the patient's eyes in use.

FIGS. 18-1 to 18-3 schematically show clip components according toalternative examples of the disclosed technology. FIG. 18-1 shows anexample in which the inner and outer edges 51(1), 51(2) of the clipcomponent 50 are generally parallel. In FIG. 18-2, the outer edge 51(2)is scooped or curved inwards in the side of nose regions. FIG. 18-3 issimilar to FIG. 18-2 but with the outer edge 51(2) curved more inwardlyin the side of nose regions.

Structure to Fit More Chin Shapes

In an example, the clip component may be shaped or structured at thechin region to fit more patients. For example, the clip component may bestructured to decrease the amount of foam that would go in the eyeand/or improve seal and comfort at the lower mouth.

FIGS. 19 to 22 show cross-sections of clip components in a chin regionaccording to alternative examples of the disclosed technology. In FIG.19, the clip component 50(1) includes a cross-sectional configurationsimilar to the clip component 50 described above. In FIG. 20, the clipcomponent 50(2) provides a platform 62 at the chin region that is slopedgenerally inwards, e.g., compared to that of FIG. 19. In FIG. 21, theclip component 50(3) provides a platform 62 at the chin region that israised and sloped generally inwards, e.g., compared to that of FIG. 19.In FIG. 22, the clip component 50(4) provides a platform 62 that israised from the cheek region down to the chin region.

Forehead Support Pad

In the illustrated example, as shown in FIG. 1, a forehead support 25 isprovided to the mask frame 20 to provide a support and stabilitymechanism between the mask system and the patient's forehead in use. Asillustrated, the forehead support 25 includes an adjustment knob or dial26 that is rotatable to extend or retract a forehead support plate 27that carries one or more forehead support pads or cushions 28, e.g.,constructed of an elastomeric material (e.g., silicone). Further detailsand examples of such forehead support are disclosed in PCT PublicationNo. WO 2006/074517, which is incorporated herein by reference in itsentirety.

In an alternative example, the one or more forehead support pads may beat least partially constructed of foam (e.g., die cut foam orcompression cut foam) or other conformable or compliant material, e.g.,gel, fabric. Preferably, the conformable forehead support pad may beremovably attachable to the forehead support, e.g., to allow forreplacement.

FIGS. 23 and 24 show a forehead support pad 92 according to an exampleof the disclosed technology. As illustrated, the forehead support pad 92includes a conformable cushioning component 94 structured to contact thepatient's forehead and an attachment component 95 provided to thecushioning component and structured to secure the forehead support padto the forehead support plate of the forehead support.

The attachment component 95 is constructed of a material (e.g., moldedof plastic, nylon, etc.) having greater hardness or structural integritythan the conformable cushioning component (e.g., foam) so as to aidassembly of the conformable cushioning component to the forehead supportplate 27.

The cushioning component 94 may be attached to attachment component 95in any suitable manner. For example, the cushioning component may beadhesive backed or glued to the attachment component. In anotherexample, the cushioning component may be co-molded to the attachmentcomponent.

In the illustrated example, the cushioning component 94 includes a pairof pads 96(1), 96(2) that are joined to one another by a bridge portion97.

The attachment component 95 includes a pair of pad support portions98(1), 98(2) that are joined to one another by a bridge portion 99. Eachpad support portion 98(1), 98(2) includes a first side providing asurface 91 adapted to engage and support a respective pad 96(1), 96(2)of the cushioning component. The surface may be contoured to help shapethe cushioning component, e.g., general concave contour to conform topatient's forehead profile. A second or opposite side of each padsupport portion 98(1), 98(2) includes an attachment head 93 to attachthe forehead support pad to the forehead support plate.

The bridge portion 99 is generally bowed or curved to allow flexibilitybetween the pair of pad support portions 98(1), 98(2), and hence allowflexibility between the pair of pads 96(1), 96(2).

As illustrated, the attachment head 93 protrudes rearwardly from the padsupport portion and adapted to be inserted into and interlock with arespective aperture formed in the forehead support plate 27, e.g., witha snap fit.

For example, as shown in FIG. 24, each attachment head 93 includes twolegs 93(1) separated by a space 93(2) that provides a clip feature forsnap-fit retention. The free end of each leg 93(1) is tapered to allowreceipt of the legs into a respective aperture in the forehead supportplate. The space or gap 93(2) between the legs allows the legs to flexinwardly when inserted into the respective aperture. A recessed portionis provided to each leg which provides a shoulder or retaining feature93(4) for interlocking with the forehead support plate when theattachment head reaches it operative position and the legs resilientlyreturn to original form.

The attachment component may have other suitable structures orgeometries. In an example, the attachment between the attachment headand the pad support portion may be structured to enhance gimballing orflexibility.

For example, FIGS. 25-1 to 25-5 show a pad support portion 98 attachedto an attachment head 93 according to alternative examples of thedisclosed technology, FIG. 25-1 shows an arrangement similar to that ofFIG. 24 in which the attachment head 93 is coupled to the pad supportportion 98 by a stem 93(3). In FIG. 25-2, the stem 93(3) includes abowed or curved portion 93(3)-1 to enhance flexibility between theattachment head and the pad support portion. In FIG. 25-3, the padsupport portion 98 includes elongated, parallel openings 98(3) toenhance flexibility at its connection with the stem 93(3). In FIG. 25-4,the stem 93(3) includes a longer and thinner configuration to enhanceits flexibility. In FIG. 25-5, the pad support portion 98 includes aseries of openings 98(3) in the shape of a cross to enhance flexibilityat its connection with the stem 93(3). However, it should be appreciatedthat other suitable geometries are possible.

FIG. 26 shows an alternative example in which a conformable cushioningcomponent 292, e.g., constructed of foam, is wrapped over the existingforehead support plate 27 of the forehead support 25. As illustrated,the conformable cushioning component 292 may include slots 292(1) thatallow respective ends of the forehead support plate to passtherethrough.

In the illustrated example of FIG. 23, the foam forehead support pad 92is used along with a foam cushioning component 40, which provides a masksystem having an all-foam patient contact. The foam forehead support padmay provide a softer feel on the patient's forehead, e.g., compared tosilicone which can be relatively sticky. Also, the dial-type foreheadsupport 25 as described above or any other forehead support adjustmentmechanism may be used as the foam forehead support pad is conformable.

In the illustrated examples, the forehead support pad 92 is a separatecomponent from the cushioning component 40. In an alternative example,one or more portions of the forehead support pad may be integrated withthe cushioning component 40 and/or the cushion-to-frame component 50.

Forehead Support Pad Position on Forehead

In an example, the cushioning component may be structured to ensure thatthe forehead support pad is positioned substantially on the patient'sforehead in use, i.e., cushioning component not sitting too low on thepatient's face which may cause the forehead support pad to be positionedtoo low on the forehead or on the patient's eyebrows.

For example, FIG. 27 is a cross-sectional view of a clip component 50and cushioning component 40 according to an example of the disclosedtechnology. In FIG. 28, the cushion contacting side and platform thereofof the clip component 50 may be moved towards the patient's chin, e.g.,by about 5 mm with respect to the clip component of FIG. 27. Asillustrated, the inner wall of the clip component 50 includes an angledsection 50-1 which allows the frame contacting side to maintain itsposition while allow the platform to be moved down towards the patient'schin. In FIG. 29, the position of the shims used to cut the foamcushioning component 40 may be changed to move the apex of thecushioning component at the nasal bridge and chin further up, i.e.,towards the patient's forehead. In FIG. 30, the height of the clipcomponent 50 may be reduced (measured from the nasal bridge region tothe chin region).

While the technology has been described in connection with severalexamples, it is to be understood that the technology is not to belimited to the disclosed examples, but on the contrary, is intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the technology. Also, the various examplesdescribed above may be implemented in conjunction with other examples,e.g., one or more aspects of one example may be combined with aspects ofanother example to realize yet other examples. Further, each independentfeature or component of any given assembly may constitute an additionalexample. In addition, while the technology has particular application topatients who suffer from OSA, it is to be appreciated that patients whosuffer from other illnesses (e.g., congestive heart failure, diabetes,morbid obesity, stroke, bariatric surgery, etc.) can derive benefit fromthe above teachings. Moreover, the above teachings have applicabilitywith patients and non-patients alike in non-medical applications.

1. An interfacing structure for a mask system, comprising: a cushioncomponent adapted to contact the patient's face in use; and acushion-to-frame component provided to the cushion component, thecushion-to-frame component structured to secure the cushion component toa mask frame of the mask system, the cushion-to-frame componentincluding a cushion side adapted to interface with the cushion componentand a frame side adapted to interface with the mask frame, wherein thecushion side includes a platform to engage and support the cushioncomponent, the platform providing an engagement surface to engage thecushion component and inner and outer flanges provided to opposing endsof the platform to guide, support and/or retain the cushion component onthe platform.
 2. An interfacing structure according to claim 1, whereinthe cushion component includes foam.
 3. An interfacing structureaccording to claim 1, wherein the engagement surface is non-linear alongits width.
 4. An interfacing structure according to claim 1, furthercomprising an adhesive to attach the cushion component to the cushionside.
 5. An interfacing structure according to claim 1, wherein theframe side includes a pair of side clip portions and a bottom clipportion adapted to engage respective slots provided on the mask frame.6. An interfacing structure according to claim 5, wherein the side clipportions include a different structure or configuration than the bottomclip portion.
 7. An interfacing structure according to claim 5, whereineach of the side and bottom clip portions extend from an inner wall ofthe cushion-to-frame component, the inner wall including one or moreribs adjacent each of the clip portions structured and arranged tocontrol flexibility of each of the clip portions.
 8. An interfacingstructure according to claim 7, wherein at least one rib is providedadjacent the bottom clip portion.
 9. An interfacing structure accordingto claim 7, further comprising side ribs and a central rib between theside ribs provided adjacent each side clip portion.
 10. An interfacingstructure according to claim 9, wherein the central rib is contouredalong its length and protrudes further outwardly from the inner wallthan the side ribs.
 11. An interfacing structure according to claim 5,wherein the cushion-to-frame component includes a base portion adjacenteach side clip portion, the base portion including one or more recessesor cut-outs.
 12. An interfacing structure according to claim 1, whereinthe cushion-to-frame component includes a sealing lip extending along aninner wall of the cushion-to-frame component, the sealing lip adapted toengage the mask frame and provide a seal.
 13. An interfacing structureaccording to claim 12, wherein the sealing lip is provided between anupper surface and a lower surface of the inner wall, and the lowersurface is offset outwards from the upper surface to increase a lengthof the sealing lip.
 14. An interfacing structure according to claim 13,wherein a length of the sealing lip from the upper surface is about 2.2mm and a length of the sealing lip from the lower surface is about 2.0mm.
 15. An interfacing structure according to claim 12, wherein thesealing lip includes a thickness of about 0.35 mm.
 16. An interfacingstructure according to claim 12, wherein the sealing lip includes aninternal radius of about 0.1 mm.
 17. An interfacing structure accordingto claim 12, wherein the sealing lip includes an angle of about 40-60°with respect to the inner wall.
 18. An interfacing structure accordingto claim 1, wherein the cushion-to-frame component is molded of TPE. 19.An interfacing structure according to claim 18, wherein thecushion-to-frame component is molded of Hytrel®.
 20. An interfacingstructure according to claim 19, wherein the cushion-to-frame componentis molded of Hytrel®
 5556. 21. An interfacing structure according toclaim 1, further comprising arcuate-shaped protrusions or wings providedto respective sides of the cushion side of the cushion-to-framecomponent adjacent side of nose regions of the cushion component.
 22. Aninterfacing structure according to claim 1, wherein the cushioncomponent includes scalloped or inwardly curved surfaces in side of noseregions.
 23. A mask system, comprising: a mask frame; and an interfacingstructure according to claim 1 provided to the mask frame.
 24. A masksystem according to claim 23, further comprising a forehead supportprovided to the frame, the forehead support structured to carry one ormore forehead support pads at least partially constructed of foam.
 25. Amask system according to claim 24, wherein the forehead support padincludes a conformable cushioning component structured to contact thepatient's forehead and an attachment component provided to thecushioning component and structured to secure the forehead support padto the forehead support.
 26. A mask system according to claim 25,wherein the attachment component is constructed of a material havinggreater hardness or structural integrity than the conformable cushioningcomponent.
 27. A mask system according to claim 25, wherein thecushioning component is attached to attachment component by an adhesive.28. A mask system according to claim 25, wherein the cushioningcomponent includes a pair of pads that are joined to one another by abridge portion.
 29. A mask system according to claim 25, wherein theattachment component includes a pair of pad support portions that arejoined to one another by a bridge portion.
 30. A mask system accordingto claim 25, wherein the attachment component includes an attachmenthead structured to attach the forehead support pad to the foreheadsupport with a snap fit.
 31. An interfacing structure for a mask system,comprising: a cushion component adapted to contact the patient's face inuse; and a cushion-to-frame component provided to the cushion component,the cushion-to-frame component structured to secure the cushioncomponent to a mask frame of the mask system, wherein thecushion-to-frame component is molded of TPE.
 32. An interfacingstructure according to claim 31, wherein the cushion-to-frame componentis molded of Hytrel®.
 33. An interfacing structure according to claim32, wherein the cushion-to-frame component is molded of Hytrel® 5556.34. An interfacing structure according to claim 31, wherein thecushion-to-frame component includes clip portions adapted to engagerespective slots provided on the mask frame.
 35. An interfacingstructure for a mask system, comprising: a cushion component adapted tocontact the patient's face in use; and a cushion-to-frame componentprovided to the cushion component, the cushion-to-frame componentstructured to secure the cushion component to a mask frame of the masksystem, wherein the cushion-to-frame component includes a sealing lipadapted to engage the mask frame and provide a seal, the sealing lipbeing disposed at an angle and having a length to enhance seal andcontrol ease of insertion.
 36. An interfacing structure for a masksystem, comprising: a cushion component adapted to contact the patient'sface in use; and a cushion-to-frame component provided to the cushioncomponent, the cushion-to-frame component structured to secure thecushion component to a mask frame of the mask system, wherein thecushion-to-frame component includes a sealing lip adapted toprogressively engage the mask frame by (i) adjusting the position of thesealing lip's height on a side wall of the cushion-to-frame component,(ii) varying the length of the sealing lip around the perimeter of thecushion-to-frame component, and/or (iii) varying the angle of thesealing lip with respect to the inner wall.
 37. An interfacing structurefor a mask system, comprising: a cushion component adapted to contactthe patient's face in use; and a cushion-to-frame component provided tothe cushion component, the cushion-to-frame component structured tosecure the cushion component to a mask frame of the mask system, thecushion-to-frame component including at least one clip portion adaptedto engage a respective slot provided on the mask frame, the at least oneclip portion extending from a wall of the cushion-to-frame component,wherein the wall includes a rib adjacent each of the side clip portionsstructured and arranged to engage the mask frame and enhance the forceat which a sealing lip adjacent the clip portion engages the frame. 38.An interfacing structure for a mask system, comprising: a cushioncomponent adapted to contact a region of the patient's face in use, saidcushion component being manufactured to have a two-dimensional shape;and a cushion-to-frame component including a cushion surface constructedand arranged to have a three dimensional shape and to impart that shapeto the cushion component when the cushion component is assembled to thecushion surface of the cushion-to-frame component.
 39. A method formanufacturing an interfacing structure for a mask system, comprising:providing a cushion-to-frame component including a cushion surfacehaving a three-dimensional shape; and assembling a cushion componenthaving a two-dimension shape to the cushion surface of thecushion-to-frame component such that that the cushion-to-frame componentimparts its three-dimensional shape to the cushion component.